AN IMPROVED METHOD AND APPARATUS FOR CLOSING A SEVERED STERNUM
Technical Field of the Invention
This invention relates generally to surgical devices. More specifically, the present invention relates to improved sternum clamping devices and methods to reapproximate a patient's sternum following a partial median sternotomy.
Background of the Invention A partial or median sternotomy is a procedure by which a saw or other appropriate cutting instrument is used to make a midline, longitudinal incision along a portion or the
entire axial length of the patient's sternum, allowing two opposing sternal halves to be separated laterally. A large opening into the thoracic cavity is thus created, through which a surgeon may directly visualize and operate upon the heart and other thoracic organs or tissues. Following such a procedure, the two severed sternal halves must be reapproximated.
Traditionally, sternal halves have been reapproximated with stainless steel wires
wrapped around or through the sternal halves so as to exert medial compression thereon and twisted together to approximate the sternum. Other methods of sternum repair include the use of band or strap assemblies which typically include a locking mechanism, which secures a strap in a closed looped configuration about the sternum positions. While utilization of steel wires and strap assemblies have been widely accepted for sternum repair, these devices
present a number of disadvantages. Steel wires can and do break, and provide insufficient(non-uniform) clamping force resulting in sternal nonunion. Steel wires are difficult to maneuver and place around the sternum. The cut ends of the steel wires are also
sharp and can pierce through the surgeon's gloves or fingers. In addition, the small diameter of the steel wires can cause the wires to migrate into or through the tissue surrounding the sternum region or into the sternal bone itself over time and result in sternal disintegration into small segments. This can lead to significant patient pain and discomfort in addition to slowing the postoperative recovery and increasing the risk of sternal infection. Moreover, the strap mechanisms of band assemblies are often relatively structurally complex and are difficult to precisely apply about the sternum. There are also healing problems associated with the use of steel wires and band assemblies due to improper forces exerted by these devices which can cause unwanted bone movements leading to raking and rubbing of surrounding tissue or bone.
Several other techniques of sternal reapproximation have been proposed both for primary closure following a median sternotomy and for reclosure following post-operative emergency surgical procedures. One such sternal fixation device is described in USPN
6,051 ,007 entitled External Closure Device and Instruments Therefor, the entire contents of which are incorporated by reference.
The sternum closure device of USPN 6,051 ,007 however is clearly absent the benefits and teachings of the instant invention. Most particularly foot portions (20, 40) of the '007 device are limited to two points of contact on the posterior section of a patient's
sternum and consequently lack the stability and positioning enhancement features of the
instant invention. Quite distinguishable, from the '007 patent and other devices practiced in the contemporary art is the present invention's novel structure which advances the art, as does the invention embodiment disclosed in association with patent application, Serial Number 10/001 ,988, filed on October 31 , 2001 , by allowing and encouraging divided sternal plates to be tilted upward to maximize healing surfaces in apposition to each other, thus
avoiding downward plate deflection and substandard healing. Also consistent with parent application, Serial Number 10/001,988, and distinguishable from devices of the contemporary art, the instant invention spans the width of at least two interspaces, thus
eliminating the need for more than one device for tight/secured closure over the same sternal area. The four securing leg and foot structures ofthe instant invention improve pulmonary mechanics by assisting in the alignment of ribs across the sternotomy allowing for simultaneous right and left rib elevation symmetrically across the sternum and chest. The
projection member structures ofthe instant invention leverage the tight connections provided by fascia and muscle, strengthens pulmonary compliance and allows for distribution of energy and positioning strength to be spread evenly throughout the sternum. Most distinguishable from the contemporary art, the instant invention enables fragmented
segments ofthe stemum to be held in place for healing, as opposed to single plate structures ofthe contemporary art which concentrate (as opposed to distribute) energy occasionally to a crushing central point thereby allowing laterally displaced fragments to further displace. The above is a brief description of some deficiencies in the prior art and advantages ofthe present invention. Other features, advantages, and embodiments ofthe invention will be apparent to those skilled in the art from the following description, accompanying drawings and claims.
Brief Summary of the Invention
The present invention provides an improved device and method for reapproximating the stemal halves of a patient's stemum following a median or partial sternotomy, and facilitates ready access to the thoracic cavity during or after a medical procedure advanced the art by overcoming the sternal nonunion problems inherent in prior art devices.
The present invention advances the present art and provides for an improved sternum clamping device which employs first and second clamp structures; and angled foot members which facilitate tilting divided stemal plates upward in apposition to each other avoiding prevent downward deflection to enhance healing.
Another significant object of the instant invention is to provide for two separate clamping devices from opposing sides which decreases the amount of metal needed for clamping/securing structures.
An additional object ofthe invention is to provide for two independently adjustable locking means which distribute the strength of a stemum closure, equally and laterally, and essentially appose opposing rib segments along the same plane.
Another object ofthe instant invention is to provide a device wherein the width of two separate intraspaces associated with the invention' s clamping structures to eliminate the need for multiple devices to facilitate sternum closure over the same area.
Yet another object ofthe instant invention is to provide for quick release mechanism
which will prevent tissue ingrowth into the clamp release mechanism.
A further object of the instant invention is to provide a small locking member and clamping apparatus which results in decreased apparatus profile and weight but not closure strength.
Yet another object of the instant invention is to provide for two member locking mechanism which improves pulmonary mechanics by assisting in the alignment ofthe ribs across a sternotomy, thus permitting simultaneous right and left rib elevation symmetrically across the stemum and chest. A further object of the instant invention is to provide for a dual clamp locking mechanism which leverages ribs connected by fascia and muscle strengthening pulmonary
compliance.
An additional object ofthe instant invention is to provide a mechanism and method by which the distribution of closure energy and strength are spread evenly throughout the stemum enabling even fragmented segments ofthe stemum to be held in place for healing.
Yet another object ofthe instant invention is to provide an apparatus by which the strength of the sternal closure is actually increased and distributed by means of a double clamping mechanism over a correspondingly positioned rib pair.
An additional further object ofthe instant invention is to provide an apparatus by which the alignment of apposing ribs actually increases the strength ofthe closure as well as pulmonary force expiratory volume.
Yet another object ofthe instant invention is to provide an apparatus in which the
edges are smooth to prevent dehiscence or extrusion.
The following disclosure further teaches the structure and practice of a method for a stemal closure device, which comprises impermanently joined, sliding and receiving attachment structures that are adapted for intercostal positioning between at least two correspondingly positioned rib pairs substantially surrounding a patient' s stemum with each
structure having a cross member, a plurality of integrated leg and foot portions, a plurality of stemum engagement surfaces, and an end portion.
The invention disclosed herein advances the art and is a continuation in part of United States patent application, Serial Number 10/001 ,988, filed October 31 , 2001. Said previously filed parent application is incorporated by reference herein in its entirety.
A significant object ofthe instant invention is to facilitate sternum closure via two separate attachment stmctures from opposing sides which decreases the amount of metal needed for clamping/securing structures.
Another object ofthe instant invention is to provide a device wherein the width of two separate sequentially occurring rip intraspaces are associated with the invention's clamping stmctures to eliminate need for multiple devices to facilitate stemum closure over the same area.
Yet another object of the instant invention is to provide for a single locking mechanism which improves pulmonary mechamcs by assisting in the alignment ofthe ribs across a sternotomy, thus permitting simultaneous right and left rib elevation symmetrically across the stemum and chest. A further obj ect ofthe instant invention is to provide for a single locking mechanism which leverages ribs connected by fascia and muscle strengthening pulmonary compliance. Another object of the instant invention is to provide for an easily accessible and expeditious means by which sliding and receiving attachment stmctures may be engaged to, and disengaged from on another.
Another object ofthe instant invention is its single set screw which when removed, allows rapid, complete disarticulation of the apparatus allowing almost instantaneous surgical access in the event of an emergency procedure.
Additional objects and advantages of the invention are set forth, in part, in the
description which follows and, in part, will be apparent to one of ordinary skill in the art
from the description and/or from the practice ofthe invention. These together with other
objects ofthe invention, along with the various features of novelty which characterize the
invention, are pointed out with particularity in the claims annexed to and forming a part of
this disclosure. For a better understanding ofthe invention, its operating advantages and the
specific objects attained by its uses, reference would be had to the accompanying drawings,
depictions and descriptive matter in which there is illustrated preferred embodiments and
results ofthe invention.
Other objects and further scope of the applicability of the present invention will become apparent from the detailed description to follow, taken in conjunction with the accompanying drawings wherein like parts are designated by like reference numerals.
Description of the Drawings
Figure 1 illustrates clamp members ofthe instant invention in a disassociated or non- joined state.
Figure la illustrates the instant invention's first and second clamp members in a
joined or associated state.
Figure 2 is an isolated illustration of a single clamp member.
Figure 2a is a bottom view elevation ofthe clamp member illustrated in Figure 2.
Figure 2b is a top view elevation ofthe clamp member illustrated in Figure 2.
Figure 2c is an inward view side elevation ofthe clamp member illustrated in Figure
2.
Figure 2d is an outward view side elevation of the clamp member illustrated in
Figure 2.
Figure 2e is a posterior view elevation ofthe clamp member illustrated in Figure 2.
Figure 2f is a frontal view elevation ofthe clamp member illustrated in Figure 2.
Figure 3 illustrates a frontal view of multiple stemal closure devices intercostally positioned above and below at least two correspondingly positioned rib pairs and
substantially surrounding a patient's stemum.
Figure 4 illustrates a posterior view of multiple stemal closure devices intercostally positioned above and below at least two correspondingly positioned rib pairs and
substantially surrounding a patient's stemum.
Figure 5 illustrates a joined frontal view perspective of the invention's first and
second clamp members.
Figure 6 illustrates joined first and second clamp members in a bottom view elevation.
Figure 7 illustrates a block diagram of method of sequence steps when deploying first and second clamp members of the instant invention to facilitate closure and healing of a
severed stemum.
Figure 8 illustrates a frontal view of one embodiment of the instant invention as practiced in its joined or associated state.
Figure 9 illustrates a posterior view of one embodiment ofthe instant invention as practiced in its joined or associated state.
Figure 10 illustrates a side view of one embodiment of the instant invention as practiced in its joined or associated state. Figure 11 illustrates distinguishable elements of one embodiment of the instant invention in a disassociated state.
Figure 12 illustrates a posterior view of one embodiment ofthe instant invention's sliding attachment structure with the invention's locking member positioned therein.
Figure 13 illustrates a posterior view ofthe instant invention intercostally positioned above and below at least two correspondingly positioned rib pairs and substantially surrounding a patient's stemum.
Figure 14 illustrates a frontal view ofthe instant invention intercostally positioned above and below at least two correspondingly positioned rib pairs and substantially
surrounding a patient's stemum.
Detailed Description of the Preferred Embodiment
While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides for inventive concepts capable of being embodied in a variety of specific contexts. The specific
embodiments discussed herein are merely illustrative of specific manners in which to make and use the invention and are not to be interpreted as limiting the scope of the instant invention. While the invention has been described with a certain degree of particularity, it is clear that changes may be made in the details of construction, sequence of methodology step execution without departing from the spirit and scope of this disclosure. It is understood that the invention is not limited to the embodiments set forth herein for purposes of exemplification, but is to be limited only by the scope of the attached claim or claims, including the full range of equivalency to which each element thereof is entitled.
The claims and the specification describe the invention presented and the terms that are employed in the claims draw their meaning from the use of such terms in the specification. The same terms employed in the prior art may be broader in meaning than specifically employed herein. Whenever there is a question between the broader definition
of such terms used in the prior art and the more specific use ofthe terms herein, the more specific meaning is intended.
Referring to the drawings like numerals indicate like elements, embodiments of
improved stemal closure devices according to the present invention are shown in Figures 1
through 14.
Figure 1 illustrates clamp members ofthe instant invention in a disassociated or non- joined state wherein first and second clamp structures (3,4) are shown. As illustrated in Figure 1, said first and second clamp members (3,4) are identical in structure. Each ofthe
invention's clamp members further embody a plurality of integrated leg 6 and foot members 7. It will be noted that said foot members on portions 7 are angled upwardly at
approximately 20° to assist in the alignment of ribs across a severed sternum permitting simultaneous right and left rib elevation to lie symmetrically across the sternum and chest. In so doing, the elevation provided by angled foot stmctures 7 further assist in the alignment of apposing ribs thus increasing the position strength of invention closure as well as pulmonary forced expiratory volume.
Further illustrated in Figure 1 are end portions 13 of each clamp generally located at the uppermost portions of said leg members 6, as are projection members 15 and general Ushaped receiving chambers 17.Figure 1 further illustrates a plurality of stemum posterior engagement surfaces located generally on the uppermost angled portion 10 of said foot members 7. As will be discussed in association with Figure 2a, each clamp member also
embodies a frontal sternum engagement surface 19.
As can be readily envisioned, projection members 15 are slidably received into the generally Ushaped receiving chambers 17 of each clamp member (3,4). Once so positioned, said projection members 15 are secured in place via or at least one locking stmcture such as
but not limited to a set screw 9, which is accommodated within a recessed, or bevel shaped 8 aperture located on the invention's cross member 5 said aperture 8 providing which
provides access to said inserted projection member 15. Figure 1 A illustrates the first and second clamp members 3, 4, illustrated in Figure
1 , in a on engaged or secured status wherein like numerals reference like invention elements. In Figure la, each clamp's projection member 15, has entered a receiving chamber 17
encouraging said clamp members 3, 4 to be drawn together such that the end portion of clamp member 3, is drawn toward the end portion 14 of clamp member 4, and clamp
member 4 is drawn toward the end portion 13 of clamp member 3.
Figure 2 illustrates a perspective view ofthe invention's clamp member as practiced in one embodiment wherein further detail ofthe invention's generally Ushaped receiving chamber 17 and recessed aperture 8 may be observed. As will be readily appreciated by those skilled in the art, said receiving chamber 17 is manifested as a Ushaped downward fold of material constituting the invention's cross member 5. Through extensive testing, it has been determined that such downward folding of said cross member 5 is most efficient to facilitate enhanced healing of a severed stemum while reducing potential for co-mingling fascia or interconnecting fibrous tissue. However, it is conceivably that the manifestation of said receiving chamber 17 could be accommodated via an upward Ushaped folding of said cross member 5 or indeed additional or secondary materials attached thereto creating a similarly intended receiving chamber.
In Figure 2 the recess or beveled shaped aperture 8 extends through the uppermost surface of said cross member 5 to allow insertion therein of a said screw 9 or other similarly intended stmcture. Once a projection member 15 of an opposing clamp member is inserted in receiving chamber 17, said screw 9 or said screw equivalent stmcture is inserted within said beveled aperture 8 and tightened into place via a threaded or functionally equivalent means to allow the uppermost portion of said set screw stmcture to position itself flush with, or below, the uppermost surface cross-member 5. Once so positioned, the set screw stmcture 9 rests upon the inserted projection 15 member so as to fix said projection member's position within said chamber 17. Such fixation, or positioning is facilitated via influencing pressure induced by said screw stmcture 's 9 contact with said inserted projection member 15. Further illustrated in Figure 2 is the invention's frontal stemum engagement surface generally located in the proximity of element 19.
Figure 2a is a bottom elevation ofthe clamp member illustrated in Figure 2 wherein like numerals indicate like elements of the embodiment of the invention disclosed in association with Figure 1. The bottom illustration of Figure 2a should be interpreted as viewing a horizontally positioned patient looking towards the patient's head from the
patient's feet.
Figure 2b is a top elevation ofthe clamp member illustrated in Figure 2 wherein like numerals indicate like elements ofthe embodiment ofthe invention disclosed in association with Figure 1. The top illustration of Figure 2b should be interpreted as viewing a horizontally positioned patient looking towards the patient' s feet and as viewed downwardly
towards the patient' s head.
Figure 2c is an outward side elevation view of the clamp member illustrated in Figure 2 wherein like numerals indicate like elements ofthe embodiment ofthe invention disclosed in association with Figure 1.
Figure 2d is an inward side elevation view ofthe clamp member illustrated in Figure
2 wherein like numerals indicate like elements ofthe embodiment ofthe invention disclosed in association with Figure 1.
Figure 2e is a posterior view elevation ofthe clamp member illustrated in Figure 2 wherein like numerals indicate like elements ofthe embodiment ofthe invention disclosed
in association with Figure 1. Figure 2f is a frontal elevation view of the clamp member illustrated in Figure 2 wherein like numerals indicate like elements ofthe embodiment ofthe invention disclosed in association with Figure 1.
Figure 3 illustrates intercostal positioning of multiple first and second clamp
members 3, 4 positioned across a severed stemum 50 and between at least two
correspondingly positioned rib pairs( 31,32). In Figure 3, said first and second clamp members 3, 4 have been secured together across a severed stemum 50 via insertion of each clamp's projection member 15 into an apposing clamp member's receiving chamber and having once been 50 inserted, secured in place via tightening of a set screw stmcture 9 which has been inserted through an aperture the uppermost portion of each clamp's cross member 5.
Figure 4 illustrates a posterior view of multiple stemal closure devices intercostally positioned above and below at least two correspondingly positioned rib pairs (31,32) and substantially surrounding a patient's stemum. In Figure 4, the angled foot portions of the instant invention 7 are illustrated positioned against the posterior surface of a severed
stemum 50 via each foot member's posterior engagement surface designated as element 10.
Figure 5 illustrates the frontal view perspective of the invention's closing device wherein like numerals reference like elements.
Figure 6 illustrates joined first and second clamp members in a bottom view elevation wherein like numerals reference like elements.
Figure 7 illustrates a block diagram ofthe method sequence steps when deploying
first and second clamp members ofthe instant invention to facilitate closure and healing of
a several sternum.
In Figure 7 first and second clamp members are first positioned about a respective stemal half and between at least two correspondingly positioned rib pairs 61. Following such
positioning, the projection member of each clamp member is then aligned for subsequent insertion into receiving members manifested as a generally Ushaped stmcture on apposing clamp members 63. The foot members of each clamp member are then aligned and properly positioned on the posterior section ofthe respective stemal halves 65 and said first
and second clamp members are removably secured by drawing each member towards one another ensuring complementary insertion of each clamp member's projection member into its reciprocal receiving chamber 67. The clamp members are then secured in place by insertion of a set screw or similarly intended structure through a beveled aperture at each clamp's cross member and into said inserted projection members 69.
The following disclosure teaches the structure and practice of a method for a stemal closure device, which comprises impermanently jawing, sliding and receiving attachment stmctures that are adapted for intercostal positioning between at least two correspondingly positioned rib pairs substantially surrounding a patient's stemum with each stmcture having a cross member, a plurality of integrated leg and foot portions, a plurality of sternum engagement surfaces, and an end portion.
Figure 8 illustrates a frontal view of one embodiment ofthe instant invention when
practiced in a joined or associated state. As can be seen in Figure 8, a sliding attachment stmcture 70 comprises a cross member 72, a plurality of leg stmctures 74, and a plurality of projection members 76 with each projection member further embodying a number of angularly disposed teeth like stmctures 780 which are inwardly disposed and positioned on the innermost edges of each said projection members 76.
Continuing with Figure 8, the projection members 76 are inserted through, generally u-shaped receiving chambers formed on the lower most surface of receiving attachment structure 80 (receiving chamber not shown in Figure 9, discussed further in association with Figure 9). Also shown in Figure 8, is a connection means, such as but not limited to, a screw, lock, pin, or other similarly intended device 84 and a catch member (illustrated in association with Figures 11 and 12) which is inserted through an aperture 86 embodied
within said receiving attachment stmcture 802. Said connection means providing an easily
accessible and expeditious means of engaging and disengaging attachment stmctures 70 and 80, thereby allowing rapid removal of said stmcture.
Figure 9 illustrates a posterior view of one embodiment ofthe instant invention as practiced in its joined or associated state. Turning now to Figure 2. In Figure 9, the invention's receiving attachment stmcture 12 is shown further illustrating its receiving chambers 82 through which the invention's projection members 76 are inserted. Figure 9 further discloses a plurality of stemum engagement surfaces 75, which are located at the terminus ofthe invention's integrated leg portions 74. In practice, the invention's projection members 76 are slidably received into and through said receiving chambers 82 whereupon the invention's projection members teeth like stmctures 78 are
correspondingly engaged by a locking member (not shown) teeth like stmctures, such that one way traversing of said receiving chambers 82 is allowed. The teeth like stmctures 78 of each projection member 76 and locking member further possess complimenting engagement surfaces which allow for secure positioning once a desired closure position has been realized. Further discussion and disclosure of the interaction between the instant invention's locking member and projection member teeth like surfaces will be provided in association with Figures 11 and 12.
Figure 10 illustrates a side view of one embodiment of the instant invention as practiced in a joined or associated state. Turning now to Figure 10. In Figure 10, further distinction may be observed with respect to the invention's leg
73, foot 74, and sternum engagement surfaces 75. A side view illustration of the engagement of the inventions receiving chamber 82 is also provided, as is a beveled or otherwise angled projection member positioning limitation stmcture 82. Said limitation stmcture 82 intended to provide the means by which a maximum projection member
insertion may be observed/facilitated.
Figure 11 illustrates distinguishable elements of one embodiment of the instant invention in a dis-associated state. Turning now to Figure 11.
In Figure 11, the invention's locking member 90 may be observed. The locking member is a resiliently tensioned stmcture, typically, though not limitedly embodied ofthe same material as the invention's receiving and sliding attachment stmctures 70 and 80. The catching member 90 further possess angularly disposed teeth like stmctures 92 which are outwardly positioned at first and second ends (96, 98) ofthe catching member. A securing aperture 24 is substantially centered between said ends (99, 98). Figure 11 further provides
a frontal view of the invention's sliding member as well as a posterior view of the invention's attachment receiving stmcture 80.
Figure 12 illustrates a frontal view of one embodiment of the instant invention's sliding attachment stmcture 80 with the invention's locking member 90 positioned therein.
Turning now to Figure 12. In Figure 12, the invention's projection members 76 are shown for purposes of illustration and full and complete disclosure with inwardly positioned angularly disposed teeth like stmctures 78 located on each ofthe invention's projection members. Said teeth like stmctures 78 engaging in outwardly positioned teeth like stmctures 92 located at first and second ends (96, 98) ofthe invention's locking member 90. As the invention's locking member is housed and accommodated within the posterior of the invention's receiving chambers, Figure 12 allows comprehension and appreciation of the one way insertion orientation ofthe slidably adjustable stemum closure device
Figure 13 illustrates a posterior view ofthe instant invention intercostally positioned above and below at least two correspondingly positioned rib pairs (31, 32) and substantially
surrounding a patient's sternum.
Figure 14 illustrates a frontal view ofthe instant invention intercostally positioned above and below at least two correspondingly positioned rib pairs 31, 32 and substantially surrounding a patient's stemum 50. It will be apparent to those skilled in the art that various modifications and variations
can be made in the constmction, configuration, and/or operation ofthe present invention
without departing from the scope or spirit of the invention. For example, in the
embodiments mentioned above, variations in the materials used to make each element ofthe
invention may vary without departing from the scope ofthe invention. Thus, it is intended
that the present invention cover the modifications and variations ofthe invention provided
they come within the scope ofthe appended claims and their equivalents.
While this invention has been described to illustrative embodiments, this description is not to be construed in a limiting sense. Various modifications and combinations ofthe illustrative embodiments as well as other embodiments will be apparent to those skilled in the art upon referencing this disclosure. It is therefore intended that this disclosure encompass any such modifications or embodiments.